Senior Director, Development (ECD and MCED Products)

Location: Remote USA; listed office location: San Carlos, California

Salary: $268,200–$335,200 USD annually

Company

hirify.global develops cell-free DNA testing and personalized genetic diagnostics for oncology, women’s health, and organ health.

What you will do

• Define and own the multi-year development strategy and technical lifecycle for the ECD and MCED portfolio.
• Lead phase-gated development, design verification, and validation of NGS-based, cfDNA, methylation, and other analyte-based IVD products.
• Set priorities, allocate people, budgets, and laboratory resources, and make or recommend portfolio go/no-go decisions.
• Partner with clinical, medical, biostatistics, regulatory, research, bioinformatics, software, quality, and commercial functions on pivotal studies, performance claims, and product delivery.
• Define PMA evidence strategies and represent development activities in FDA pre-submission meetings and advisory panels.
• Build and mentor a leadership organization while maintaining audit readiness and design-control practices.

Requirements

• Advanced degree in Molecular Biology, Biomedical Engineering, Life Sciences, or a related field, such as a PhD or MD.
• At least 7 years of experience in IVD or diagnostic device development under design controls.
• At least 7 years directing scientific or technical organizations, including 5 or more years managing senior managers or directors.
• Deep expertise in complex NGS diagnostic assays, analytical validation, cfDNA-based liquid biopsy, molecular oncology, and transfer to commercial laboratories.
• Experience leading technical and performance evidence for an FDA PMA, De Novo, or equivalent high-complexity IVD approval, including senior-level FDA interactions.
• Knowledge of FDA regulations, ISO 13485:2016, ISO 14971, IVDR, IEC 62304, and QMS requirements.

Nice to have

• Principal technical leadership on an NGS-based oncology PMA or equivalent international IVD approval.
• Experience with large prospective or pivotal cancer-screening studies and multi-cancer classification or cancer signal origin prediction.
• Experience translating Laboratory Developed Tests into FDA-regulated IVD products.
• Experience with bioinformatics pipelines and machine-learning classifiers in regulated IVD products.

Culture & Benefits

• Cross-functional environment involving scientific, clinical, technical, regulatory, and commercial disciplines.
• Medical, dental, vision, life, and disability benefits for eligible employees and dependents.
• Free testing for employees and immediate family members, plus fertility care benefits.
• Pregnancy and baby bonding leave, 401k benefits, commuter benefits, and an employee referral program.